JP2013516205A - Customized intraoral skeleton extension device and its use for almost continuous skeleton extension - Google Patents

Abstract

The present invention relates to a customized intraoral skeleton extension device comprising two fixing means (1, 2) mounted on the mandible at two fixation points and located on either side of the callus. The skeleton extension device includes: a) a threaded cylindrical rail (6) connecting the two fixing means (1, 2); and b) a bone guided and extended to slide on the rail (6). A movable carriage (10) mounted on a portion of the movable carriage (10), the movable carriage having a screw thread that complements the thread of the rail and a gear screw (11) that engages the rail; c) a gear screw (11 ) And a pin (12) for controlling the rotation of the gear screw (11), which is substantially parallel to the rail (6) and has two bearings (13) arranged on the movable carriage (10). , 14) supported on either side of the gear screw; d) the pin (12) passes while it is located at one end (16) of the gear screw (11) and on the other hand to the end (16) Of bearing (14) facing A wall at least one resilient element located in (18) (15), comprising a. The present invention can be used for reconstruction of bone parts that are defective or defective due to osteogenesis extension.
[Selection] Figure 4

Description

  The present invention relates to a customized intraoral skeleton extension device for oral and maxillofacial surgery, in particular the device capable of reconfiguring the mandible and a very specific use of the device to achieve skeleton extension in a nearly continuous state. .

  Replacement or repair of missing mandibular bone fragments, for example, for bone healing after tumor resection, severe trauma, or more simply after osteotomy performed to modify bone tissue, Such surgical technique is necessary.

  The callus extension method, which is one of the techniques, is a surgical operation used to reconstruct bone deficiencies and bone defects or extend the bones of the human body, and consists of placing a mechanical device called a skeleton extension device. Its function is to mount a callus generated by osteotomy for extending the bone in a space corresponding to a bone defect.

  Regardless of the treated organ, the surgery is performed in several steps that can be subdivided into the following aspects. The first is a procedure for performing surgery, mainly consisting of subperiosteal osteotomy, which breaks the bone to be reconstructed and divides it into at least two parts. After the incubation period, the parts are gradually separated from each other by the skeleton extension device. In the stable period, the bone becomes solid and clearly precedes the removal of the skeleton extension device.

  Some of the callus extension techniques have already been used to recover interrupting substance loss (ISL) in the case of mandibular, maxillary or cheekbones, especially facial ballistic trauma (eg after a suicide attempt). It has been used successfully. Bone, gums and surrounding soft tissue can be reconstructed by the callus extension method. Thus, several skeleton extension devices are known in the prior art, corresponding to various techniques for reconstructing bone and facial soft tissue defects in the lower and middle of the face.

  U.S. Pat. No. 6,057,028, filed May 2, 1997, filed by Medicon, describes a mandibular skeleton extension system that implements the first technique. A small screw jack with two ends secured to each side of the osteogenic callus pulls the osteogenic callus so that replacement bone tissue is newly formed at that location. The entire device is contained within the oral cavity, and the screw can be operated from the outside with a screwdriver.

  However, the device has particularly large expansion and contraction parts, and a plurality of parts cannot be arranged on the same side surface of the mandible.

  A slightly smaller device is described in U.S. Pat. No. 5,849,834 published on April 23, 1988, which consists of two symmetrical parts guided by two parallel rods integrated with a fixed point. Consists of a small double screw jack that operates. The entire device is in the form of a variable length rectangle and the extension is adjusted with a small jack.

  Chin's device can be very effective and is particularly suitable for the treatment of the rising branch of the lower jaw, but its mechanical structure is rather complex.

  Patent Document 3 published on March 12, 1998 by M. Mommaerts is based on the same principle, but relates to an apparatus which is another embodiment. The rear end of the telescopic screw system is not fixed to a drilling bar, which is common in implantology, but is placed directly on the insert located in the upper branch of the lower jaw (mandibular branch). The system is simpler and more compact, but can only be treated in the far posterior jaw region.

  The advantage of the skeletal extension device is that its intraoral application is simple and similar to the osteosynthesis method, it is easy to operate and is therefore acceptable to the patient without problems.

  However, the above prior art shows that none of the skeletal extension devices continue to achieve the result and speed of bone extension, and there is still a deficiency in therapeutic indication. All of the devices operate in a discontinuous manner, i.e., the reconstructed bone is pulled periodically so that it is moved abruptly every 10 millimeters, and then for several hours, with the traction of the skeletal extension device due to the natural regenerative capacity of the bone. The resulting gap is filled, and then the reconstructed bone is abruptly moved tens of millimeters to activate the skeleton extension (the reference protocol accepted by all practitioners has allowed traction on the reconstructed bone The method is performed on a daily or twice daily basis, and traction is approximately 0.8-1 mm per day).

  Furthermore, known skeleton extension devices usually have one or two disadvantages: very cumbersome; bone reconstruction cannot be directly performed along the trajectory specific to the patient being treated, Or if it is partially curved, it cannot be reconstructed directly.

  The intraoral skeletal extension device of the present invention can overcome the above deficiencies: the force applied to move the reconstructed bone is almost continued; although it is small, this is particularly due to the oral characteristics of the mechanical device. It is important; it can be configured to reflect the patient, i.e., be patient specific, and ideally follows the straight and curved parts that the bone should follow after bone reconstruction.

  The shape of the skeletal extension device of the present invention is based on a material deficit after surgery or trauma, the location of this material deficit and the remaining bone volume available and finally the image that the patient wants to repair, before the computer is operated on. It can be decided by using.

EP0770359 WO98 / 16163 WO98 / 09557

  Accordingly, a first object of the present invention is to provide a customized intraoral skeleton extension designed to reconstruct bone parts missing or missing after tumor resection, trauma, bone deformity or osteogenesis failure with the callus extension method. Device.

  In a known manner, the bone must be stimulated via tensile stress, and the skeleton extension device is attached to the mandible in a fixed position and comprises two fixing means located on each side of the callus.

More specifically, the present invention, as its purpose, is an intraoral skeleton extension device, the main feature of which is the intraoral skeleton extension device,
a) a threaded cylindrical rail connecting two fixing means,
b) a movable carriage mounted on a portion of the bone that is guided and extended so as to slide on the rail, and the carriage has a thread that complements the thread of the rail and engages the rail With screws,
c) a pin for controlling the rotation of the gear screw integrated with the gear screw, the pin being substantially parallel to the rail and disposed on the movable carriage on either side of the gear screw; Supported by two bearings,
d) at least one elastic part passing through the pin, on the one hand located on one end of the gear screw and on the other hand on the inner wall of the bearing facing the end, the two parts of the movable carriage The distance between the inner walls of the bearings includes the length of the gear screw being longer due to the height of the elastic part when the elastic part is stationary, i.e. relaxed.

  This elastic part is ideally either a lock-type washer, a so-called Belleville conical spring washer or a stack of conical washers arranged in pairs. However, without being limited thereto, this elastic component may be a spring, a diaphragm or other elastic element such as, for example, a compressible cylinder made of elastomer.

  The pin that controls the rotation of the gear screw allows the practitioner or patient himself to easily operate the skeleton extension device, with the actuator head locked in a recess made in the outer wall of the bearing where the elastic part is located. Prepare.

  According to various possible embodiments for the operation, the head provided on the pin for controlling the rotation of the gear screw is provided with one slit or two slits or screwdrivers or hexagonal wrench arranged on the cross. There is a six-sided blind hole that allows the head to rotate.

  In order to fully fix the skeleton extension device of the present invention to ensure complete use, each of the two fixing means and the movable carriage is mounted on the portion of the bone that is extended with the mandible by at least two attachment points. The

  According to various possible embodiments, the form of the means for fixing the movable carriage to the part of the bone to be extended is an I- or Y- or X-shaped crossing warning sign.

  Ideally, the threaded cylindrical rail of the skeleton extension device of the present invention comprises two diametrical planes relative to each other so that the movable carriage is guided to slide completely on the rail. The movable carriage, which is guided to slide, is cage-shaped, the two walls of the cage being parallel to the longitudinal axis of the rail and at the two ends by one and the other of the two bearings supporting the pin of the gear screw. Joined, the walls are separated by a distance slightly longer than the thickness of the rail between the two planes. For the same purpose, the threaded cylindrical rail may have a third plane opposite the bottom of the movable carriage.

  In the first embodiment of the skeleton extension device of the present invention, the rail is linear.

  In a second embodiment of the skeleton extension device of the present invention, the rail forms at least one curve. In this case, the different curve (s) of the rail are in a single plane, which plane is perpendicular to the rail plane to maintain threading near the neutral element of the rail.

  Regardless of the embodiment of the skeleton extension device of the present invention, each component is advantageously made of a biocompatible material, such as titanium or a titanium alloy.

  The present invention also provides for the very specific use of a skeleton extension device according to the above-mentioned features for skeleton extension in a substantially continuous manner, the use of which is the end of a gear screw not present in the elastic part. It is better due to the fact that when the part comes into contact again with the inner wall of the bearing facing the end, the rotation of the pin integrated with the gear screw is controlled to compress the elastic part again.

  The various essential descriptions make it clear to those skilled in the art the additional advantages provided by the intraoral skeleton extension device of the present invention over the prior art.

  The detailed description of the invention is set forth in the following description with reference to the accompanying drawings. It should be noted that the drawings merely illustrate the contents of the specification and do not limit the scope of the present invention.

1 is a front perspective view of a customized intraoral skeleton extension device of the present invention implemented in a first embodiment in which the threaded cylindrical rail is straight. FIG. FIG. 6 is a front perspective view of a customized intraoral skeleton extension device of the present invention implemented in a second embodiment in which the threaded cylindrical rail is curved. It is a perspective view of the rear part of the skeleton extension apparatus of FIG. A more detailed view of a movable carriage guided to slide on a threaded cylindrical rail is shown in front view. It is a perspective view of the movable carriage shown by FIG. It is a perspective view of one of the two fixing means of the skeleton extension device of the present invention, and the fixing means is fixed to the lower jaw body on one side of the callus.

  The customized intraosseous skeleton extension device of the present invention is referred to as two fixing means, left 1 and right 2, which are fixed to the mandibular body of the patient at fixing points arranged on each side of the callus, as determined by the operator. Including known embodiments.

  In order to fix the fixing point, the two fixing means 1 and 2 each preferably comprise two knobs 3 and 4 which together form an angle of, for example, about 90-120 °, each knob being for example 2 There are two openings 5 through which screws or spindles (not shown) are passed, so that the fixing means are securely fixed to the immobile bone part of the mandible.

  The threaded cylindrical rail 6 connecting the two fixing means 1 and 2 is the basis of the skeleton extension device according to the invention in that the trajectory of the reconstructed bone is thereby determined very accurately.

  In this effect, the two end portions of the rail 6 are locked to the recesses 7 provided in the inner walls 8 of the two fixing means 1 and 2 on the opposite sides of the knobs 3 and 4.

  Each end of the rail 6 is secured to the end of the rail 6 by means of a screw 9 passing through a threaded hole drilled between the top of the fixing means 1, 2 (or the base or longitudinal wall) and the housing 7. It is fixed to the recess 7 that penetrates.

  The movable carriage 10 that slides on the rail 6 and is guided by the rail 6 is fixed to the portion of the bone to be extended.

  Since the movable carriage 10 is slid, the movable carriage 10 includes a gear screw 11 having a screw that complements the screw of the rail 6 and engages the screw. The pitch of the gear screw / rail thread unit is selected to match the displacement values conventionally used in skeleton extension.

  The gear screw 11 has a through hole extending along the longitudinal axis of the screw, and a central pin 12 exceeding each side of the gear screw 11 is locked to the through hole to control the rotation of the screw. There is a function. This pin 12 is firmly attached or integrated with the gear screw 11 by welding or by adhesion, for example by cyanoacrylate adhesive.

  Thus, the pin 12 thus integrated with the gear screw 11 is substantially parallel to the fixed rail 6 and is supported by two bearings, left 13 and right 14, disposed on the movable carriage 10 on each side of the gear screw. .

  Finally, at least one elastic component 15 traversed by the pin 12 is located on one end 16 of the gear screw 11 on the one hand and on the inner wall 18 of the bearing 14 facing the end 16 on the other hand, The distance between the inner walls 17 and 18 of the two bearings 13 and 14 is equal to the length of the gear screw 11 which is increased by the height of the elastic part 15 when the elastic part 15 is stationary, that is, relaxed.

  The center pin 12 exceeds each side of the gear screw 11 to be supported by the bearings 13 and 14 in a housing drilled in the inner wall 17 of the bearing 13 and in a guide drilled in the inner wall 18 of the bearing 14, The guide passes through the bearing 14 and appears in the outer wall 19.

  A recess 20 having a diameter longer than the diameter of the guide is formed in the outer wall 19, and the end of the central pin 12 of the gear screw 11 is provided with a head 21 that can be received in the recess 20 in a complementary manner.

  From the above, the central pin 12 has the screw 12 and the elastic part 15 arranged in a predetermined position between the two bearings 13 and 14 with respect to the inner walls 17 and 18, and then the pin 12 is a guide of the bearing 14, It is understood that the elastic part 15 and then the gear screw 11 are mounted so as to pass through, and finally accommodated in the bearing 13 and then integrated into the gear screw 11.

  The two ends of the central pin 12 are free to rotate within bearings 13 and 14 that support the central pin.

  Due to this configuration, the depth of the housing drilled in the inner wall 17 of the bearing 13 is at least equal to the length of the portion of the central pin 12 that extends beyond the gear screw 11 and penetrates the housing. The length of the protruding portion is longer than the maximum thickness loss experienced by the elastic part during compression of the elastic part.

  The head 21 of the central pin 12 is further in the form of a slit that can be engaged with a screwdriver or two slits arranged in a cross or a hexagonal blind hole as shown in FIG. Means 22 are provided to allow the pin 12 to rotate.

  Since the center pin 12 and the gear screw 11 are integrated with each other, the rotation operation of the head 21 of the pin 12 by a screwdriver or a hexagon wrench controls the rotation of the gear screw 11 as a whole.

  The elastic part 15 fitted with the movable carriage 10 is selected to operate in the axial direction as a spring with low space requirements and relative rigidity. Thus, the force required to compress the elastic part is selected to be slightly less than the force that separates the extended bone portion from the bone portion that does not move after the fracture.

  In this way, the elastic part 15 is an elastic washer, for example a conical washer called a Belleville conical spring washer or a stack of such conical washers that are arranged in pairs, preferably a lock-type washer, It may be a ring washer that is greatly deformed in the axial direction in the collision area where the collision has occurred.

  Thus, the elastic component 15 is a lock-type washer exemplified in all the attached drawings of the present specification. However, the elastic part 15 can be made in a technically equivalent shape to the washer, for example in the form of a compressible cylinder made of springs, diaphragms or elastomers.

  Finally, the movable carriage 10 is provided with a fastening means for the bone part to be extended by the skeleton. The means is, for example, a wing 23 that extends beyond each side of the carriage and is integrated with the carriage, and has an I shape, a Y shape, or an X-shaped crossing warning sign shown in FIGS.

  Each wing 23 of the X-shaped railroad crossing warning mark is advantageous in that two holes 24 through which screws or spindles (not shown) are passed to which the movable carriage 10 is securely fixed to the bone portion where the skeleton is extended are drilled. is there.

  From the above, the rotation of the gear screw 11 is controlled by a screwdriver or a hexagon wrench that operates the head 21 of the central pin 12 integrated with the gear screw 11, and the carriage 10 is not displaced or at least slightly moved, that is, It will be appreciated that the elastic washer 15 can be compressed without performing this action of moving the extended bone portion away from the stationary bone portion.

  In the illustrated example, when this rotation operation is executed in the counterclockwise direction, the elastic washer 15 is gradually compressed, and the gear screw 11 presses the elastic washer at its end 16 and the other end 30 of the gear screw. Is separated from the inner wall 17 of the bearing 13.

  With this deformation, the elastic washer receives energy equal to the force exerted by the force capable of compressing the elastic washer and stores it in the form of latent elastic energy.

  Indeed, during the rotation of the gear screw, the washer 15 is compressed like a spring, but the part of the bone to be extended is immobile or slightly moved. Thereafter, the latent elastic energy stored in the washer 15 is released, and the energy has an effect of gradually restoring the initial stationary shape, that is, relaxing until the latent elastic energy becomes zero. That is, the washer 15 is located at the tip 16 of the fixed gear screw and relaxes, thus resisting the bearing 14: the carriage 10 moves the same from left to right as indicated by the arrow 25 in FIG. Move slowly and always drive the bone part to be extended with the same tempo movement. Thus, the extension of the skeleton is almost continuous compared to the conventional skeleton extension device. Furthermore, the latest research suggests that bone formation performance is improved when skeleton extension is performed as continuously as possible. Thus, the skeleton extension device of the present invention can increase the success rate of the treatment and can reduce the time required.

  In order to extend the skeleton in a continuous or nearly continuous manner, the practitioner (or patient) contacts the inner wall 17 of the bearing 13 where the end 30 of the gear screw 11 not on the elastic washer 15 faces the end 30 ( Then, the operation is reliably repeated while the elastic washer 15 is compressed by actuating the head 21 of the central pin 12 of the gear screw. In this way, since the skeleton extension process continues, the practitioner actually compresses the washer 15 every day or twice a day, that is, reduces the thickness of the washer by several tens to 2 millimeters, and gradually at the same distance. It can increase the part of the bone that is extended relative to the part of the stationary bone.

  The movable carriage 10 of the skeleton extension device of the present invention must be completely guided by the rail 6 as long as its skeleton extension is required.

  In this effect, the standard threaded rod from which the rail 6 is made has a specific machining that provides two diametrically paired planes 26, substantially parallel to the knobs 3 of the fixing means 1 and 2, over the length of the rod. Take the process.

  According to the selectively complementary structure, the movable carriage 10 is cage-shaped and its two side walls, namely the front wall 27 and the rear wall 28, are parallel to the longitudinal axis of the rail 6 and to the plane 26 of the rail 6. Are joined at two ends by one and the other of the bearings 13 and 14, and the two walls 27 and 28 are further separated by a distance slightly longer than the thickness of the rail 6 between two planes.

  In the first embodiment, the most common is that the rail 6 is linear as shown in FIG.

  However, the provision of two planes 26 can achieve any complex embodiment, where the rail 6 forms one or more curves, and the portion of the bone that is extended by the practitioner is ideally displaced.

  Examples of single curve rails are shown in FIGS.

  However, this rail can be curved in a customized manner and may contain multiple curves with the same concave or reverse concave surface overall, i.e. the rail may be as similar as possible to the inner shape of the patient's jaw, The limitation is that the curve is in a single plane, and that plane is perpendicular to the rail plane 26, which means that when the curve is made, the rod is in the vicinity of the neutral element of the rail that is not stretched or compressed. This is considered to maintain the original threading. In this way, the nominal characteristics of the screw head profile and the threaded rod pitch are maintained, and the rail screw fully engages the gear screw unaffected regardless of the number and shape of the rail curves. .

  Thus, the skeleton extension device of the present invention can be patient specific and can be made in a customized manner from data obtained using a computer prior to surgery.

  Another advantage of the skeleton extension device is that it is extremely compact. The total thickness including the fixture is indeed 6 mm. It is clear that this specificity is most important, especially from the intraoral characteristics of the device.

  Due to its intraoral characteristics, the components of the skeleton extension device of the present invention, including the retaining screw, are made of a biocompatible material, such as titanium or a titanium alloy.

  In yet another embodiment, in order to further improve the stability of the mechanism, the threaded rail 6 corresponding to the above is extended in the entire length of the lower portion 31 of the rail, that is, on the bottom 32 of the cage constituting the movable carriage 10. A skeleton extension device with an opposing third plane can easily be conceived. Therefore, the movable carriage 10 has three inner sides, that is, two side walls, the front wall 27, the rear wall 28, and the wall 32 existing on the bottom 32 in the vicinity of the three planes 26 and 31 provided on the rail 6. , Better guided along the rail 6. In this embodiment, except for the attachment zone between the planes, the upper part of the rail which is essential for operating the gear screw 11, that is, the threading necessary for moving the carriage 10 is essential.

  Of course, the present invention is not limited to the preferred embodiment described above.

  The present invention includes possible variations of the embodiments within the scope defined by the claims.

Claims (14)

A customized intraosseous skeletal extension device designed for reconstruction by callus extension of a missing or defective bone part after tumor resection, trauma, bone deformity or osteogenesis failure, said extension device Is an extension device of the type comprising two fixing means (1, 2) mounted on the mandible at a fixing point and located on either side of the callus,
a) a threaded cylindrical rail (6) connecting the two fixing means (1, 2);
b) A movable carriage (10) mounted on the portion of the bone that is guided and extended so as to slide on the rail (6), the movable carriage comprising threads that complement the rail threads. A gear screw (11) that engages the rail,
c) A pin (12) for controlling the rotation of the gear screw (11) integrated with the gear screw (11), the pin being substantially parallel to the rail (6) and disposed on the movable carriage (10). Supported on either side of the gear screw by two bearings (13, 14),
d) the pin (12) passes, on the one hand located on one end (16) of the gear screw (11) and on the other hand on the inner wall (18) of the bearing (14) facing the end (16) The distance away from the inner walls (17, 18) of the two bearings (13, 14) of the movable carriage (10), including at least one elastic part (15), is when the elastic part (15) is stationary, i.e. relaxed. An intraoral skeleton extension device, characterized in that it is equal to the length of the gear screw (11) which increases with the height of the elastic part (15).   The intraoral skeleton extension device according to claim 1, characterized in that the elastic part (15) is a lock-type elastic washer or a Belleville conical spring washer or a stack of the washers.   2. An intraoral skeleton extension device according to claim 1, characterized in that the elastic part (15) is a spring or a diaphragm or a compressible cylinder, for example made of elastomer.   The pin (12) for controlling the rotation of the gear screw (11) is an actuator locked in a recess (20) made in the outer wall (19) of the bearing (14) in which the elastic part (15) is located. The intraoral skeleton extension device according to any one of claims 1 to 3, further comprising a head (21).   The head (21) provided on the pin (12) that controls the rotation of the gear screw (11) is arranged in a slit (22) that can be turned by a screwdriver or a hexagon wrench, or a cross. 5. An intra-oral skeleton extension device according to claim 4, characterized in that there are two slits or a hexagonal blind hole (22).   The two fixing means (1, 2) and the movable carriage (10) of the intraoral skeleton extension device are each provided with a knob (3, 4) and a wing (23), and the fixing means (1, 2) and the movable carriage ( 10) has two openings (5 and 24) through which screws or spindles pass to ensure that the fixing means (1,2) and the movable carriage (10) are respectively attached to the mandibular body and the part of the bone to be extended. The intra-oral skeleton extension device according to any one of claims 1 to 5, further comprising:   7. Oral cavity according to claim 6, characterized in that the means (23) for fixing the movable carriage (10) to the part of the bone to be extended is in the form of an I- or Y- or X-shaped crossing warning sign. Endoskeleton extension device.   The threaded cylindrical rail (6) of the intraoral skeleton extension device has two diametrically opposite planes (26), and the movable carriage (10) guided to slide on the rail is cage-shaped. The two walls (27, 28) of the cage are parallel to the longitudinal axis of the rail and on one and the other of the two bearings (13, 14) that support the pin (12) of the gear screw (11). The two ends are joined and the two walls (27, 28) are separated by a distance slightly longer than the thickness of the rail (6) between the two planes (26) of the rail (6). The intraoral skeleton extension device according to any one of claims 1 to 7, wherein   The intraoral skeleton extension according to claim 8, characterized in that the threaded cylindrical rail (6) of the intraoral skeleton extension device has a third plane facing the bottom (32) of the movable carriage (10). apparatus.   The intracranial skeleton extension device according to any one of claims 1 to 9, characterized in that the threaded cylindrical rail (6) is linear.   The intra-oral skeleton extension device according to any one of claims 1 to 9, characterized in that the rail (6) of the intra-oral skeleton extension device forms at least one curve.   The different curves or different curves of the rail (6) are in one plane, which plane is perpendicular to the plane of the rail (26) to keep the screw near the neutral element (29) of the rail. The intraoral skeleton extension device according to claim 11, wherein   The intraoral skeleton extension device according to any one of claims 1 to 12, wherein each component of the intraoral skeleton extension device is made of a biocompatible material, for example, titanium or a titanium alloy.   Use of an intraoral skeleton extension device for skeleton extension in a substantially continuous mode, wherein the rotation of the integrated pin (12) of the gear screw (11) is elastic. When the end (30) of the gear screw not located on the part (15) comes into contact with the inner wall (17) of the bearing (13) facing the end (30) again, the elastic part (15) is compressed again. Use of an intraoral skeleton extension device, characterized in that it is controlled.

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